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A U.S. senator is urging the FDA to act on a potential shortage of the antibiotic doxycycline while he mulls legislation that would allow the agency to step in sooner to deal with shortages. Read More
The FDA has cited two compounding pharmacies for making unapproved and contaminated drugs, and for poor sterile processing practices, the latest indication that the agency won’t let up on larger facilities. Read More
The FDA was not happy that Elite Laboratories’ quality unit failed to validate and review various product batches before distribution, landing the generic drug maker a Form 483. Read More
The FDA slapped positron emission tomography (PET) drug manufacturer Cardinal Health with a Form 483 for poor data integrity and investigations into quality problems. Read More
Marcus Research Laboratory was handed a Form 483 for not performing stability testing or properly monitoring the production process for the active pharmaceutical ingredient iodine. Read More
The FDA slapped an Indian manufacturer with a warning letter for creating phony records, falsifying training tests and failing to clean up a moldy and insect-infested facility. Read More
Amgen is recalling nine lots of its anemia drug Aranesp after a small number of syringes were found to potentially contain cellulose and/or polyester particles. Read More
A deluge of warning letters to compounding pharmacies appears to have jolted the industry into taking FDA enforcement more seriously, quality experts tell DGR. Read More
Drugmakers are worried that FDA draft guidance on how to identify and report counterfeit or suspicious goods could lead to numerous false alarms and potential shortages unless the guidance is amended. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More